Our bioanalytical experts have regulatory expertise in product characterization, pharmacokinetics and immunogenicity, for both brand-name biologics and biosimilars. Our experience can help with any of your biosimilar testing challenges and take your biosimilar from discovery phase through Phase III studies and beyond.
We have decades of experience supporting biologics and biosimilars programs, including monoclonal antibodies, metabolic hormones and immunomodulatory drugs such as Trastuzumab, Bevacizumab, Cetuximab and Adalimumab, making us your ideal partner for bioanalytical services.
Following the latest U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) regulations and guidance, we tailor bioanalytical and characterization packages to meet your distinct biosimilar development needs. We use the latest technologies and procedures to ensure accuracy, adherence to standards and on-time delivery of critical data, no matter the size of project.
We have leading experience using the several instruments and platforms for conducting immunogenicity and PK studies, biomarker studies, cell-based assays to support the development of biosimilars. Whether we are helping you develop and validate assays, analyze samples, or transferring previously developed methods, Eurofins Bioanalytical Services can deliver high quality data suitable for regulatory submission.
Learn More About The Instruments We Use
Assessing the difference between a biosimilar and a brand-name biologic is a complex issue, which presents different challenges for every biosimilar. Therefore, there is no “one size fits all” way to do biosimilars analysis. Eurofins Bioanalytical Services has extensive experience with immunogenicity testing, PK, and biosimilar comparability studies and our expertise in the development of biologics and biosimilars can help you find the optimal solution for your biosimilar.